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BCG versus epirubicin in the prophylaxis of multiple superficial bladder tumours: Results of a prospective randomized study using modified treatment schemes

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Abstract

A prospective randomized trial on 94 eligible patients evaluated and compared the efficacy of adjuvant intravesical epirubicin and bacillus Calmette-Guérin (BCG) after complete resection of multifocal superficial bladder cancer. BCG treatment schedule consisted of an induction 6-week course of instillations (150 mg Pasteur BCG per instillation) and single maintenance doses to patients who remained free of recurrences at follow-up examinations for a total treatment period of 2 years. These initial responders received additionally a separate 4-week course of therapy 6 months after the start of treatment. Chemoprophylaxis included an early (on the second postoperative day) instillation followed by 4 weekly treatments with epirubicin (50 mg per instillation) and then by 10 monthly treatments for the initial responders during the first year of follow-up and at every follow-up examination for a total treatment period of 2 years. The overall treatment results did not differ significantly between the 2 arms (54% of patients of the epirubicin group remained free of recurrences compared to 65% of those treated with BCG) for an identical mean follow-up of 35.1 months. However, a significant benefit in favour of BCG when compared with epirubicin was shown in patients who had stage T1 and grade 3 tumours and in terms of relative risk of recurrences, disease-free interval and recurrence rate per 100 patient-months. Both drugs were proved to be safe with manageable toxicity.

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Authors and Affiliations

  1. Department of Urology, University of Patras School of Medicine, Greece

    M. D. Melekos, I. Zarakovitis, K. Dandinis, E. Fokaefs, H. Chionis & G. Barbalias

  2. Department of Urology, St. Andrew General Hospital of Patras, Greece

    H. Dauaher

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  1. M. D. Melekos
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  2. I. Zarakovitis
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  3. K. Dandinis
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  4. E. Fokaefs
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  5. H. Chionis
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  6. H. Dauaher
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  7. G. Barbalias
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Melekos, M.D., Zarakovitis, I., Dandinis, K. et al. BCG versus epirubicin in the prophylaxis of multiple superficial bladder tumours: Results of a prospective randomized study using modified treatment schemes. International Urology and Nephrology 28, 499–509 (1996). https://doi.org/10.1007/BF02550957

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